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Cogent Biosciences to Initiate New Drug Application (NDA) Submission for Bezuclastinib Under Real-Time Oncology Review (RTOR)

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AI Summary

Cogent Biosciences has announced compelling data from the PEAK trial showcasing bezuclastinib's effectiveness in treating GIST. The FDA has accepted their New Drug Application under the RTOR program, facilitating a quicker review, which could significantly impact sales starting mid-2026 with additional trials planned.

Sentiment Rationale

The NDA acceptance and positive trial results provide a strong foundation for future revenue growth. Historical examples, such as similar profiles from companies like Mirati Therapeutics (MRTX), show significant stock upticks following successful trial announcements and regulatory approvals.

Trading Thesis

Buy COGT as bezuclastinib's upcoming NDA and trial results may drive stock price up in 2026.

Market-Moving

  • NDA acceptance under RTOR could expedite potential market entry and revenues.
  • Positive results from the PEAK trial may enhance investor confidence and stock valuation.
  • Initiation of Phase 2 trials for first-line GIST treatment signals ongoing innovation.
  • Presentation of trial results at a major meeting may attract further investment interest.

Key Facts

  • COGT's bezuclastinib shows significant results in GIST treatment.
  • FDA accepted NDA for bezuclastinib under RTOR program.
  • PEAK trial demonstrated mPFS of 16.5 months vs 9.2 months for sunitinib.
  • Major medical meeting planned for PEAK trial full results in H1 2026.
  • Phase 2 trial for first-line GIST patients expected to start mid-2026.

Companies Mentioned

  • Novartis (NVS): Novartis' sunitinib faces competition from COGT's bezuclastinib.

Corporate Developments

This news falls under the 'Corporate Developments' category as it highlights significant advancements in Cogent's drug pipeline and regulatory milestones. The success of bezuclastinib is critical for Cogent’s future and is likely to affect its market positioning.

Cogent Biosciences Initiates New Drug Application for Bezuclastinib under Real-Time Oncology Review Program

WALTHAM, Mass. and BOULDER, Colo., January 20, 2026 – Cogent Biosciences, Inc. (Nasdaq: COGT) announced today its plan to submit a New Drug Application (NDA) for bezuclastinib in combination with sunitinib to the FDA under the Real-Time Oncology Review (RTOR) program. This significant step aims to address the urgent needs of patients with Gastrointestinal Stromal Tumors (GIST) who are resistant to prior treatment with imatinib.

Milestone Achievement in Oncology

The acceptance of the NDA by the FDA marks a pivotal moment for Cogent Biosciences. “This milestone reflects the FDA’s acknowledgment of the significant unmet need facing patients with imatinib-resistant GIST,” stated Andrew Robbins, President and CEO of Cogent. He noted that the promising results from the PEAK trial suggest that bezuclastinib has the potential to be the first new approved therapy for this patient population in over 20 years.

PEAK Trial Outcomes

The bezuclastinib and sunitinib combination demonstrated impressive results in the PEAK trial. Key findings include:

  • Median Progression-Free Survival (mPFS): 16.5 months for the combination therapy versus 9.2 months for sunitinib alone.
  • Overall Response Rate (ORR): 46% in patients receiving the bezuclastinib combination, surpassing the 26% response rate seen with sunitinib monotherapy.
  • Risk Reduction: A 50% decrease in the risk of disease progression or death compared to the standard treatment.

These outcomes highlight the clinical benefit of utilizing bezuclastinib in patients previously treated with imatinib.

FDA’s Real-Time Oncology Review Program

The FDA’s RTOR program facilitates the review of clinical trial data prior to the complete filing of the NDA, allowing for a more expedited process. Cogent Biosciences expects to initiate the RTOR process immediately, with the full NDA submission aimed for completion by April 2026.

Future Clinical Trials and Developments

In addition to the NDA efforts, Cogent plans to present the full PEAK trial results at a prominent medical meeting in the first half of 2026. Furthermore, the company will commence a Phase 2 trial in mid-2026 to explore the bezuclastinib combination in first-line GIST patients with exon 9 mutations who are new to or recently initiated treatment with imatinib.

About Cogent Biosciences

Cogent Biosciences focuses on developing precision therapies for genetically identified diseases. The company’s lead candidate, bezuclastinib, is a selective tyrosine kinase inhibitor designed to target mutations related to GIST and systemic mastocytosis. The innovative treatment strategy aims to address critical gaps for patients with serious, genetically driven conditions.

Investor Relations

For more information on Cogent Biosciences and its pipeline, please visit cogentbio.com. Investors can follow Cogent on social media platforms, including X (formerly Twitter) and LinkedIn, for important updates.

Forward-Looking Statements

This announcement contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. These may relate to Cogent's expectations for the timeline and outcome of the NDA submission and trial results. Actual results may differ due to various risks and uncertainties. Cogent is obliged to update statements as required by law.

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